Vedolizumab Quantitation with Antibodies, Serum

Test Code
36517


CPT Codes
80280, 82397

Preferred Specimen
1.5 mL serum


Patient Preparation
For 12 hours before specimen collection do not take multivitamins or dietary supplements containing biotin (vitamin B7), which is commonly found in hair, skin, and nail supplements and multivitamins. Nivolumab (Opdivo) must be discontinued at least 4 weeks prior to testing for vedolizumab quantitation in serum.

Minimum Volume
0.75 mL


Instructions
Draw blood immediately before next scheduled dose (trough specimen). Red-top tube (no gel), or SST. Centrifuge within 2 hours of draw.


Transport Temperature
Refrigerated (cold packs)


Specimen Stability
Room temperature: Unaccptable
Refrigerated: 28 days
Frozen: 28 days


Methodology
Vedolizumab QN, S: Liquid Chromatography-Mass Spectrometry (LC-MS/MS)
Vedolizumab Ab, S: Electrochemiluminescent Bridging Immunoassay

FDA Status
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.

Setup Schedule
Monday, Tuesday, Thursday, Friday Morning
Report available: 7 Days


Reference Range
VEDOLIZUMAB QUANTITATION: Vedolizumab lower limit of quantitation =2.0 mcg/mL VEDOLIZUMAB ANTIBODIES: Antibodies to vedolizumab: <9.8 ng/mL


Clinical Significance
Assessing the unexpected loss of response to therapy with
vedolizumab over time An aid to achieving desired serum
levels of vedolizumab.




The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.